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HomeMy WebLinkAboutILA - Benton-Franklin Health District - COVID-19 Testing Site 2020I.ENTON-FRANKLIN NEALTN DI57RICT COMMUNITY SERVICES CONTRACT Between BENTON-FRANKLIN HEALTH DISTIRCT And CITY OF PASCO This Community Services Contract, hereinafter referred to as the Contract, by and between Benton -Franklin Health District (BFHD) and the City of Pasco (Contractor), and collectively known as the "Parties" is being executed in accordance with the provisions of the Interlocal Cooperation Act Chapter 39.34 RCW and for the purpose of providing an emergency response to the Covid-19 pandemic through community testing and related services as a counter measure against the pandemic. EFFECTIVE DATE: SEPTEMBER 24,2020— DECEMBER 30, 2020 Benton -Franklin Health District Phone: (509) 460-4200 7102 W. Okanogan Place Fax: (509) 460-4590 Kennewick, WA 99336 Title/Responsibility Contact Name Phone Fax Email Administrator/Signature Authority Jason Zaccaria 509-460-4567 509-460-4590 Jasonz(a�bfhd.wa.gov 509-545-5404 Contracts Manager Bonnie Hall 509-460-4553 509-460-4590 Bon nieh(Dbfhd.wa.gov EOC Incident Commander EOC Incident Commander Rick Dawson Carla Prock 509-539-1791 509-539-0874 509-460-4515 509-460-4515 Rickd(a-)bfhd.wa.gov Carlai)&bfhd.wa.gov Accountant — Accounts Payable Kyle Phillips 509-460-4580 509-460-4590 Kylep(aDbfhd.wa.gov Contractor Contacts City of Pasco — Fire Department 1011 E. Ainsworth Ave. Pasco, WA 99301 Phone: (509) 545-3426 Fax: (509) 543-5717 Responsibility Contact Name Phone Fax Email Signature Authority — City Manager Dave Zabell 509-545-5404 zabelld(a)Pasco-wa.gov Fire Chief — Primary Contact Bob Gear Gearb(a)pasco-wa9ov Site Command Craig Patterson 509-539-1976 Craig Patterson (Wcharter. net Whereas, the aforementioned Parties desire to enter into this agreement in accordance with the provisions of Interlocal Cooperation Act Chapter 39.34 RCW in which they intend to work together towards the goals and objectives set forth; And Whereas, the Parties are desirous to enter an understanding, thus setting out all necessary working arrangements that both Parties agree shall be necessary to complete this partnership; MISSION The relationship under this agreement has been established with the following intended mission of collaboration to provide testing and/or response efforts for Covid-19 to the citizens of Benton and Franklin City of Pasco — Fire Department Contract 2020 P a g e 1 311 counties with the purpose of protecting the health of the public, to support the Governor's Safe Start Washington Plan, and to provide Covid-19 testing as a counter measure against the pandemic. PURPOSE AND SCOPE The Parties intend for this Contract to provide the cornerstone and structure for the activities outlined in Exhibit B and any further binding Contracts or amendments which may be related to this partnership. INDEPENDENT CONTRACTOR The parties intend that an independent Contractor relationship will be created by this Contract. The Contractor and its employees or agents performing under this Contract are not employees or agents of the District. The Contractor, employees, or agents performing under this Contract will not hold himself/herself out as, nor claim to be, an officer or employee of the District by reason hereof, nor will the Contractor, his or her employees, or agent make any claim to right, privilege or benefit that would accrue to such officer or employee. RESPONSIBILITIES OF THE PARTIES The specific roles and responsibilities of each party are identified below as a starting point, and it is recognized that the scope of work related to this agreement is a response effort to the Covid-19 pandemic and therefore a fluid situation. It is anticipated that the needs for the response effort could evolve or change rapidly and therefore each party is committed to working collaboratively to fulfill the joint mission. As the need may arise, specific details of support to be furnished by each of the participants may be developed by amendment to this Contract or separately from this agreement in a specific, mutually acceptable manner subject to the availability of funds and resources. The parties will work together to identify appropriate time and press for decommission. It is the desire and wish of the Parties that this agreement allow the Parties to work together in such a manner that would promote a genuine atmosphere of collaboration and alliance through means of the following individual services: BENTON-FRANKLIN HEALTH DISTRICT agrees to provide the following services: • Test site selection and securing appropriate Contracting documentation with site owner • Infection control protocols, initial inventory of PPE and establishment of a system for on-going inventory management of PPE • Long term procurement of supplies --- Ongoing Specimen Collection Kits, PPE • Local procurement of technology/tents/tables/supplies to operate test site (as needed) • Logistics support — as needed to support the IMT • Patient communication design including multi-lingual patient handouts and scripts that incorporate language accessibility • Provide signage • Ordering Physician unless otherwise provided by EMS Medical Command • Lab Courier Service as provided by agreement with University of Washington Lab • Set up notification process / customer service for positive patients (consider Contract / partnering with local agency) • Provide access to Language line for on-site staff to support non-English speaking customers CITY OF PASCO — FIRE DEPARTMENT agrees to provide the following services: • Facilitate on-site staff access to interpreters or Language line for non-English speaking customers • Local test site command (scheduling/daily operations) • Sub -Contract with Columbia Safety to run daily test site operations • Ensure Local test site is supplied/organized to operation requirements • Monitor and maintain supplies to ensure adequate inventory of materials • Create and maintain a site plan including an agreed upon traffic flow with local jurisdiction City of Pasco — Fire Department Contract 2020 P g e 12 • Supervise and assure safety for all personnel while onsite • Monthly financial activity reports detailing expenditures for which reimbursement is requested • Monthly labor reports to BFHD for direct payment (Fire Department name, employee name, date(s), hours worked and any other documentation to assist DOH with validation of invoices to reimburse Fire Department for operational labor support) • Maintain additional financial backup documentation such as payroll and general ledger and provide upon request • Other reporting as requested by DOH • A positive patient experience • Provide for the following services through an agreement with Columbia Safety LLC: o Recruiting, hiring, onboarding, and continued HR support of Swabbers, Registered Technician Leads, Registered Technicians, and Traffic Safety Positions TERM OF CONTRACT The term of this Contract shall start on September 24, 2020 and be in effect until December 30, 2020 unless extended or terminated by written mutual agreement of both Parties. AUDIT REQUIREMENT A non -Federal entity that expends $750,000 or more during the non -Federal entity's fiscal year in Federal awards must have a single or program -specific audit conducted for that year in accordance with 2 CF R 200.501. If a single or program -specific audit is conducted for the funding of this agreement, Contractor shall meet the audit requirements as described in 2 CFR Part 200 Subpart F. FUNDING The Source of funding for this contract comes from the Coronavirus Relief Fund under the CARES Act. This funding has specific terms and conditions that must be met and are outlined in Exhibit A. Contractor must meet and maintain compliance with these requirements. COMPENSATION AND METHOD OF PAYMENT The maximum consideration for this contract is $1.093,000.00. BFHD will reimburse the City of Pasco —Fire Department for satisfactory completion of the services and requirements specified in this Contract, payable upon receipt and approval of a signed invoice of actual allowable costs based on monthly invoices submitted by City of Pasco to the Health District. Invoices shall be submitted by the 20th of the following month by email, fax or mail to the BFHD Accountant listed on page 1 of this agreement. Monthly invoices shall include agency name, employee name, dates, hours worked and any other documentation to assist BFHD with validation of invoices to reimburse Fire Department for operational labor support. City of Pasco -Fire Department to retain financial backup documentation such as payroll and general ledger records, and sub -Contractor records and provide upon request. Final Invoice is are due within 20 days of the end of the Contract. If final invoices and reports are not submitted within 20 days of the close of the Contract, the Health District will be relieved of all liability for payment to the City of Pasco — Fire Department of the amounts set forth in said invoice or any subsequent invoice. In-kind services are not reimbursable expenses under this agreement. DEBARMENT AND SUSPENSION CERTIFICATON This Contract is federally funded and comes from the Coronavirus Relief Funds. Entities that are debarred, suspended, or proposed for debarment by the US Government are excluded from receiving federal funds. The following acts by individuals or entities may result in permissive exclusions. This list is not all-inclusive. For a complete list refer to section 1128A b of the Social Security Act: City of Pasco — Fire Department Contract 2020 P a g 13 a. License revocation or suspension b. Fraud, kickbacks or other prohibited activities c. Entities controlled by a sanctioned individual d. Making false statements or misrepresentation of material Background checks: Contractor will ensure that all staff working in activities funded by this Contract have passed a Washington State Patrol background check upon hire and retain proof of such to be made available to District upon request. System for Award Management (SAM) site registration: Contractor shall acquire a Statewide Payee Number by registering at www.sam.ctov . DUNS number: To comply with the Federal Funding Accountability and Transparency Act and be eligible to perform the activities in this Statement of Work, Contractor agrees to register for and provide the District with its DUNS number. The Contractor, by signature of this agreement certifies that Contractor is not presently debarred, suspended, proposed for debarment, declared ineligible, or voluntarily excluded by any Federal department or agency from participating in transactions (debarred). The Contractor also agrees to notify the District immediately by providing written notice if Contractor becomes debarred during the term of this agreement. INTERNAL CONTROLS AND ACCOUNTING SYSTEM The Contractor shall establish and maintain a system of accounting and internal controls which complies with generally accepted accounting principles in accordance with the Financial Accounting Standards Board (FASB), the Governmental Accounting Standards Board (GASB) or both as applicable to the Contractors form of incorporation. ETHICS CERTIFICATION Contractor certifies that they are now and shall remain, in compliance under Chapter 42.52 RCW, Ethics in Public Service, throughout the term of this Contract. DATA USE, OWNERSHIP AND DISCLOSURE Information provided to BFHD by Contractor will be used for all necessary public health efforts as outlined in WAC 246-101. This will include sharing PHI as provided for by law for the purpose of protecting the health of the public as well as congregate data for public disclosures including publishing case counts. Any data, records or files taken off site in the course of Contractor personnel activities are to be returned to BFHD upon completion of task or upon termination of this agreement with BFHD, whichever event occurs first. The Contractor agrees that all information, records, and data collected in connection with this Contract shall be protected from unauthorized disclosure in accordance with applicable state and federal law. MAINTENANCE OF RECORDS/EVALUATIONS AND INSPECTIONS The Contractor will maintain accounts and records, including personnel, property, financial, and Contracts and other such records as deemed necessary to ensure proper accounting for all Contract funds and compliance with this Contract. Medical records shall be maintained and preserved by the Contractor in accordance with state and federal medical records statutes, included but not limited to RCW 70.41.190, 70.02.160, and standard medical records practice. If the Contractor ceases operations under this Contract, the Contractor shall be responsible for the disposition and maintenance of such medical records. HIPAA AND HITECH COMPLIANCE To the extent applicable to this Agreement, Contractor agrees to comply with the Health Information Technology for Economic and Clinical Health Act of 2009 ("HITECH ACT"), the Administrative Simplification City of Pasco — Fire Department Contract 2020 P a g 14 provisions of the Health Insurance Portability and Accountability Act of 1996, as codified at 42 USC § 1320d through d-8 ("HIPAA") and any current and future regulations promulgated under either the HITECH Act or HIPAA including without limitation the federal privacy regulations contained in 45 C.F.R. Parts 160 and 164 (the "Federal Privacy Regulations"), the federal security standards contained in 45 C.F.R. Parts 160, 162 and 164 (the "Federal Security Regulations") and the federal standards for electronic transactions, all as may be amended from time to time, and all collectively referred to herein as "HIPAA Requirements". Contractor agrees not to use or disclose any Protected Health Information (PHI) (as defined in 45 C.F.R. § 164.501) or Individually Identifiable Health Information (as defined in 42 USC § 1320d), other than as permitted by HIPAA Requirements and the terms of this Agreement. Contractor will and will cause their personnel to enter into any further agreements as necessary to facilitate compliance with HIPAA Requirements. CORRECTIVE ACTION If BFHD determines that a breach of Contract has occurred, that is, the Contractor has failed to comply with any terms or conditions of this Contract, or the Contractor has failed to provide in any manner the work or services agreed to herein, and if BFHD deems said breach to warrant corrective action, the following sequential procedure will apply: a. BFHD will notify the Contractor in writing of the nature of the breach; The Contractor shall respond in writing within three (3) working days of its receipt of such notification, which response shall indicate the steps being taken to correct the specified deficiencies. The corrective action plan shall specify the proposed completion date for bringing the Contract into compliance, which date shall not be more than ten (10) days from the date of the Contractor's response, unless BFHD specifies in writing and extension of time. b. BFHD will notify the Contractor in writing of their determination as to the sufficiency of the Contractor's corrective action plan. c. If the Contractor does not respond within the appropriate time with a corrective action plan, the Contractor's corrective action plan will be determined by BFHD to be insufficient, and the Health District may commence termination or suspension of this Contract as provided for herein. d. In addition, BFHD may withhold any payment owed the Contractor or prohibit the Contractor from incurring additional obligations of funds until BFHD is satisfied that corrective action has been taken or completed. DISPUTE RESOLUTION The parties shall use their best efforts to cooperatively resolve disputes and problems that arise in connection with this Contract. Both parties will make a good faith effort to continue without delay to carry out their respective responsibilities under this Contract while attempting to resolve the dispute. HOLD HARMLESS AND INDEMNIFICATION a. In providing services under this Contract, the Contractor is an Independent Contractor, and neither it nor its officers, agents, or employees are employees of BFHD for any purpose. The Contractor shall be responsible for all federal and/or state tax, industrial insurance, and Social Security liability that may result from the performance of and compensation for these services and shall make no claim of career service or civil service rights which may accrue to a BFHD employee under state or local law. BFHD assumes no responsibility for the payment of any compensation, wages, benefits, or taxes, by, or on behalf of the Contractor, its employees, and/or others by reason of this Contract. The Contractor shall protect, indemnify, defend and save harmless BFHD, its officers, agents, and employees from and against any and all claims, costs, and/or losses whatsoever occurring or resulting from (1) the Contractor's failure to pay any such compensation, wages, benefits, or taxes, and/or (2) the supplying to City of Pasco — Fire Department Contract 2020 P a g e 15 the Contractor of work, services, materials, or supplies by Contractor employees or suppliers in connection with or support of the performance of this Contract. b. The Contractor further agrees that it is financially responsible for and will repay BFHD all indicated amounts following an audit exception which occurs due to the negligence, intentional act, and/or failure, for any reason, to comply with the terms of this Contract by the Contractor, its officers, employees, agents, and/or representatives. This duty to repay BFHD shall not be diminished or extinguished by the prior termination of the Contract pursuant to the Terms and Termination section. c. The Contractor shall protect, defend, indemnify and save harmless BFHD, its officers, employees, and agents from any and all costs, claims, judgments, and/or awards of damages, arising out of, or in any way resulting from, the negligent acts or omissions of the Contractor, its officers, employees, subcontractors and/or agents, in its performance and/or non-performance of its obligations under this Contract. The Contractor agrees that its obligations under this subparagraph extend to any claim, demand, and/or cause of action brought by, or on behalf of, and of its employees or agents. For this purpose, the Contractor, by mutual negotiation, hereby waives, as respects BFHD only, any immunity that would otherwise be available against such claims under the Industrial Insurance provisions of Title 51 RCW. In the event BFHD incurs any judgement, award, and/or cost arising therefrom including attorneys' fees to enforce the provisions of this article, all such fees, expenses, and costs shall be recoverable from the Contractor. d. BFHD shall protect, defend, indemnify, and save harmless the Contractor, its officers, employees, and agents from any and all costs, claims, judgements, and/or awards of damages, arising out of, or in any way resulting from, the negligent acts or omissions of BFHD, its officers, employees, and/or agents, in its performance and/or non-performance of its obligations under this Contract. BFHD agrees that its obligations under this subparagraph extend to any claim, demand, and/or cause of action brought by, or on behalf of, any of its employees or agents. For this purpose, BFHD, by mutual negotiation, hereby waives, as respects the Contractor only, any immunity that would otherwise be available against such claims under the Industrial Insurance provisions of Title 51 RCW. In the event the Contractor incurs any judgement, award, and/or cost arising therefrom including attorneys' fees to enforce the provisions of this article, all such fees, expenses, and costs shall be recoverable from BFHD. e. Nothing contained within this provision shall affect and/or alter the application of any other provision contained within this Contract. f. The indemnification, protection, defense and save harmless obligations contained herein shall survive the expiration, abandonment or termination of this Contract. INSURANCE REQUIREMENTS Contractor shall procure and maintain for the duration of this Contract the following insurance coverage: General Liability Coverage General Liability Insurance, or Business Liability Insurance, including coverage for bodily injury, property damage, and Contractual liability, with the following minimum limits: Each Occurrence- $1,000,000; General Aggregate - $2,000,000. The policy shall include liability arising out of premises, operations, independent Contractors, products -completed operations, personal injury, advertising injury, and liability assumed under an insured Contract. Business Auto Liability Insurance(BAL) The Contractor shall maintain a Business Automobile Policy on all vehicles used in the performance of work under this Contract, including vehicles hired by the Contractororowned bythe Contractor's employees, volunteers or others,withthe following minimum limits: $1,000,000 per accident combined single limit. City of Pasco — Fire Department Contract 2020 P a g 16 Professional Liability Insurance (PL) The Contractor shall maintain Professional Liability Insurance or Errors & Omissions insurance, including coverage for losses caused by errors and omissions, with thefollowing minimum limits: Each Occurrence - $1,000,000; Aggregate- $2,000,000. Worker's Compensation The Contractor shall comply with all applicable Worker's Compensation, occupational disease, and occupational health and safety laws and Regulations under Title 51 RCW by the Contractor or its employees under such laws and Regulations. Employees and Volunteers Insurance required ofthe Contractor underthe Contract shall include coverage for the acts and omissions of the Contractor's employees and volunteers. Inaddition, the Contractor shall ensure that all employees and volunteers who use vehicles to transport clients or deliver services have personal automobile insurance and current driver's licenses. Separation of Insureds All insurance policies shall include coverage forcross liability and contain a "Separation of Insureds" provision. Insurers The Contractor shall obtain insurance from insurance companies identified asan admitted insurer/carrierinthe State of Washington, with a Best's Reports' rating of B++, Class VI I, orbetter. Surplus Lines insurance companies will have a rating of A-, Class VII, or better. The Contractor's membership in the Washington Cities Insurance Authority, a self-insured, governmental risk pool shall satisfy all conditions set forth in the Insurance section of this Agreement. Evidence of Coverage The Contractor shall submit to District documentation evidencing the insurance requirements of the Contractor before commencement of the work. LIMITATION OF LIABILITY BFHD and its local partners, including City of Pasco - Fire Department, are working together to develop and implement a community testing site as a counter measure against the Covid-19 pandemic and is therefore covered under the PREP Act attached hereto as Exhibit D which provides immunity to covered person for certain activities as defined in the PREP Act and delineated in the PREP ACT declaration issued by the Secretary of Health and Human Services. ASSIGNMENT/SUBCONTRACT Contractor may not assign or transfer all or any portion of this Contract or any of its rights hereunder, or delegate any of its duties hereunder without the prior written consent of the District. Any permitted assignment will not operate to relieve Contractor of any of its duties and obligations hereunder, or will such assignment affect any remedies available to the District that may arise from any breach of the provisions of this Contract. Contractor agrees to include the following language verbatim in every subcontract for services which relate to the scope of work in this Contract: "Subcontractor shall protect, defend, indemnify, and hold harmless Benton -Franklin Health District (BFHD), its officers, employees and agents from any and all costs, claims, judgements, and/or awards of damages arising out of, or in any way resulting from the negligent act or omissions of subcontractor, its officers, employees, and/or agents in connection with or in support of this Contract. City of Pasco— Fire Department Contract 2020 P a g 17 Subcontractor expressly agrees and understands that BFHD is a third parry beneficiary to this Contract and shall have the right to bring an action against subcontractor to enforce the provisions of this paragraph". NONDISCRIMINATION Contractor shall not discriminate against anyone in providing services under this Agreement on the grounds of race, color, sexual orientation, gender identity, religion, national origin, creed, marital status, age, Vietnam era or disabled veterans' status, or the present of any sensory, mental or physical disability. GENERAL PROVISIONS The Parties acknowledge and understand that they must be able to fulfill their responsibilities under this Contract in accordance with the provisions of the law and regulations that govern their activities. Nothing in the agreement is intended to negate or otherwise render ineffective any such provisions or operating procedures. The Parties assume full responsibility for their performance under the terms of this Contract. If at any time either party is unable to perform their duties or responsibilities under this Contract consistent with such party's statutory and regulatory mandates, the affected party shall immediately provide written notice to the other party to establish a date for resolution of the matter. CHANGES OR MODIFICATIONS The District may, at any time, by written notification to Contractor, make changes within the general scope of the services to be performed under this Agreement. Both parties shall execute a Contract amendment reflecting such change and an equitable adjustment of cost, period of performance or both will be made if required by the changes. CONTRACT SUSPENSION • For Investigation: In the event Contractor or any of its partners, employees, officers is investigated by a local, county, state or federal agency for a matter which the District feels may adversely affect the delivery of services under this Contract, the District may, without notice suspend the delivery of services or disallow the person(s) involved in the allegation from providing services pending final resolution of the investigation. For Suspension of Funding and work: Because the District receives both state and federal funds occasionally the District's funding source may enact a Contract suspension due to sequestration, loss of budget appropriation, or other causes. When this occurs, the District may exercise its right to suspend this Contract until the District's funding has resumed and approval to continue work has been received. At that time, the District will notify the Contractor that they may resume work. All notice to suspend or reinstate work will be in writing. Any expenses incurred during the suspension of this Contract may not be reimbursed later unless it is specifically approved at the time the Contract is reinstated. TERMINATION OF AGREEMENT • For Convenience: This Contract may be terminated by either party for convenience with 14 days written notice. If this Contract is so terminated, the parties are only liable for performance rendered or costs incurred in accordance with this Contract prior to the effective date of termination. • By Mutual Agreement: This Contract may be terminated at any time by mutual agreement of both parties. • Termination for Default: In the event the District determines the Contractor has failed to comply with the terms and conditions ofthisContract, the District has the right to suspend orterminate this Contract. District shall notify the Contractor in writing of the need to take corrective action. If corrective action isnot taken within ten (10) Business Days, this Contract maybe terminated. District reserves the right to suspend all or part of this Contract, withhold further payments, or prohibit the Contractorfrom incurring additional obligations offunds during investigation ofthe alleged compliance breach and pending corrective action by the Contractor ora decision by the Districtto terminate this Contract. City of Pasco — Fire Department Contract 2020 i a g e 18 • For Non -Allocation of Funds: The District's ability to make payments is contingent on the availability of its various funding sources. In the event funding from state, federal, or other funding sources is withdrawn, reduced, limited or suspended during the course of this Contract, the District at its sole discretion may elect to terminate this agreement in whole or in part or to renegotiate this Contract subject to new funding limitations or conditions. GOVERNING LAW This Contract shall be governed by and construed in accordance with the laws of the State of Washington. SEVERABILITY If any term or condition of this Contract is held invalid by any court, the reminder of this Contract remains valid and in full force and effect. ENTIRE AGREEMENT This Contract contains all the terms and conditions agreed upon by the parties. No other understandings, oral or otherwise, regarding the subject matter of this Contract shall be deemed to exist or to bind either of the parties. AMENDMENTS Either party may request changes to this Contract. Proposed changes which are mutually agreed upon shall be incorporated by written amendments to this Contract. NOTICE Any notice or communication required or permitted under this Contract shall be sufficiently given if delivered in person, by email, or certified mail, return receipt requested to Contracts Manager with a copy to the District Administrator at the addresses set forth on page one (1) of this Contract. AUTHORIZATION AND EXECUTION This Agreement is executed in accordance with the authority of Chapter 39.34 RCW, the Interlocal Cooperation Act. The following information is given pursuant to the provisions of RCW 39.34.030: (a) The duration of this Agreement shall be from September 24, 2020 to December 30, 2020. (b) The purpose of this Agreement is stated under section "Purpose and Scope." (c) Termination of this Agreement shall be as provided in Section "Termination of Agreement." (d) This Agreement shall be administered by the Benton -Franklin Health District. (e) Unless otherwise specifically agreed by the parties in writing, all property, personal and real, utilized by the parties hereto in the execution of this agreement shall remain the property of that party initially owning it. (f) Nothing in this Agreement shall preclude the City from contracting with another jurisdiction. City of Pasco — Fire Department Contract 2020 g e 19 By signature of this agreement, both parties agree to adhere to the terms and conditions set forth herein conditioned upon final approval of the City Council of the City of Pasco. BENION-FRANKLIN HEALTH DISTRICT Cwj 4m)6 Jasoh — Administrator Date CITY OF PASCO !�rnry;0-11--Iwwo- ATTEST: Debra C. Barham, City Clerk APPROVED AS TO FOR: Kerr Fer w, PLLC, City Attomey CRy of Ranco- Fin DepartreeM Contract 2020 a pe 110 By signature of this agreement, both parties agree to adhere to the terms and conditions set forth herein conditioned upon final approval of the City Council of the City of Pasco. BENTON-FRANKLIN HEALTH DISTRICT Jason Zaccaria — Administrator Date CITY OF PASCO r".1 1",l4rai ATTEST: Debra C. Barham, City Clerk APPROVED AS TO Kerr Fergpelruw, PLLC, City Attorney City of Pasco — Fire Department Contract 2020 � g 0 110 Exhibit A Coronavirus Relief Fund Guidance for State, Territorial, Local, and Tribal Governments Updated Sept. 2, 20201 The purpose of this document is to provide guidance to recipients of the funding available under section 601(a) of the Social Security Act, as added by section 5001 of the Coronavirus Aid, Relief, and Economic Security Act ("CARES Act"). The CARES Act established the Coronavirus Relief Fund (the "Fund") and appropriated $150 billion to the Fund. Under the CARES Act, the Fund is to be used to make payments for specified uses to States and certain local governments; the District of Columbia and U.S. Territories (consisting of the Commonwealth of Puerto Rico, the United States Virgin Islands, Guam, American Samoa, and the Commonwealth of the Northern Mariana Islands); and Tribal governments. The CARES Act provides that payments from the Fund may only be used to cover costs that - 1. are necessary expenditures incurred due to the public health emergency with respect to the Coronavirus Disease 2019 (COVID-19); 2. were not accounted for in the budget most recently approved as of March 27, 2020 (the date of enactment of the CARES Act) for the State or government; and 3. were incurred during the period that begins on March 1, 2020, and ends on December 30, 2020.2 The guidance that follows sets forth the Department of the Treasury's interpretation of these limitations on the permissible use of Fund payments. Necessary expenditures incurred due to the public health emergency The requirement that expenditures be incurred "due to" the public health emergency means that expenditures must be used for actions taken to respond to the public health emergency. These may include expenditures incurred to allow the State, territorial, local, or Tribal government to respond directly to the emergency, such as by addressing medical or public health needs, as well as expenditures incurred to respond to second -order effects of the emergency, such as by providing economic support to those suffering from employment or business interruptions due to COVID-19-related business closures. Funds may not be used to fill shortfalls in government revenue to cover expenditures that would not otherwise qualify under the statute. Although a broad range of uses is allowed, revenue replacement is not a permissible use of Fund payments. The statute also specifies that expenditures using Fund payments must be "necessary." The Department of the Treasury understands this term broadly to mean that the expenditure is reasonably necessary for its intended use in the reasonable judgment of the government officials responsible for spending Fund payments. On June 30, 2020, the guidance provided under "Costs incurred during the period that begins on March 1, 2020, and ends on December 30, 2020" was updated. On September 2, 2020, the "Supplemental Guidance on Use of Funds to Cover Payroll and Benefits of Public Employees" and "Supplemental Guidance on Use of Funds to Cover A 2 s added by section 5001 of the CARES Act. Costs not accounted for in the budget most recently approved as of March 27, 2020 The CARES Act also requires that payments be used only to cover costs that were not accounted for in the budget most recently approved as of March 27, 2020. A cost meets this requirement if either (a) the cost cannot lawfully be funded using a line item, allotment, or allocation within that budget or (b) the cost is for a substantially different use from any expected use of funds in such a line item, allotment, or allocation. The "most recently approved" budget refers to the enacted budget for the relevant fiscal period for the particular government, without taking into account subsequent supplemental appropriations enacted or other budgetary adjustments made by that government in response to the COVID-19 public health emergency. A cost is not considered to have been accounted for in a budget merely because it could be met using a budgetary stabilization fund, rainy day fund, or similar reserve account. Costs incurred during the period that begins on March 1, 2020, and ends on December 30, 2020 Finally, the CARES Act provides that payments from the Fund may only be used to cover costs that were incurred during the period that begins on March 1, 2020, and ends on December 30, 2020 (the "covered period"). Putting this requirement together with the other provisions discussed above, section 601(d) may be summarized as providing that a State, local, or tribal government may use payments from the Fund only to cover previously unbudgeted costs of necessary expenditures incurred due to the COVID-19 public health emergency during the covered period. Initial guidance released on April 22, 2020, provided that the cost of an expenditure is incurred when the recipient has expended funds to cover the cost. Upon further consideration and informed by an understanding of State, local, and tribal government practices, Treasury is clarifying that for a cost to be considered to have been incurred, performance or delivery must occur during the covered period but payment of funds need not be made during that time (though it is generally expected that this will take place within 90 days of a cost being incurred). For instance, in the case of a lease of equipment or other property, irrespective of when payment occurs, the cost of a lease payment shall be considered to have been incurred for the period of the lease that is within the covered period but not otherwise. Furthermore, in all cases it must be necessary that performance or delivery take place during the covered period. Thus the cost of a good or service received during the covered period will not be considered eligible under section 601(d) if there is no need for receipt until after the covered period has expired. Goods delivered in the covered period need not be used during the covered period in all cases. For example, the cost of a good that must be delivered in December in order to be available for use in January could be covered using payments from the Fund. Additionally, the cost of goods purchased in bulk and delivered during the covered period may be covered using payments from the Fund if a portion of the goods is ordered for use in the covered period, the bulk purchase is consistent with the recipient's usual procurement policies and practices, and it is impractical to track and record when the items were used. A recipient may use payments from the Fund to purchase a durable good that is to be used during the current period and in subsequent periods if the acquisition in the covered period was necessary due to the public health emergency. Given that it is not always possible to estimate with precision when a good or service will be needed, the touchstone in assessing the determination of need for a good or service during the covered period will be reasonableness at the time delivery or performance was sought, e.g., the time of entry into a procurement contract specifying a time for delivery. Similarly, in recognition of the likelihood of supply chain disruptions and increased demand for certain goods and services during the COVID-19 public health emergency, if a recipient enters into a contract requiring the delivery of goods or performance of services by December 30, 2020, the failure of a vendor to complete delivery or services by December 30, 2020, will not affect the ability of the recipient to use payments from the Fund to cover the cost of such goods or services if the delay is due to circumstances beyond the recipient's control. This guidance applies in a like manner to costs of subrecipient's. Thus, a grant or loan, for example, provided by a recipient using payments from the Fund must be used by the Subrecipient only to purchase (or reimburse a purchase of) goods or services for which receipt both is needed within the covered period and occurs within the covered period. The direct recipient of payments from the Fund is ultimately responsible for compliance with this limitation on use of payments from the Fund. Nonexclusive examples of eligible expenditures Eligible expenditures include, but are not limited to, payment for: 1. Medical expenses such as: • COVID-19-related expenses of public hospitals, clinics, and similar facilities. • Expenses of establishing temporary public medical facilities and other measures to increase COVID-19 treatment capacity, including related construction costs. • Costs of providing COVID-19 testing, including serological testing. • Emergency medical response expenses, including emergency medical transportation, related to COVID-19. • Expenses for establishing and operating public telemedicine capabilities for COVID-19- related treatment. 2. Public health expenses such as: • Expenses for communication and enforcement by State, territorial, local, and Tribal governments of public health orders related to COVID-19. • Expenses for acquisition and distribution of medical and protective supplies, including sanitizing products and personal protective equipment, for medical personnel, police officers, social workers, child protection services, and child welfare officers, direct service providers for older adults and individuals with disabilities in community settings, and other public health or safety workers in connection with the COVID-19 public health emergency. • Expenses for disinfection of public areas and other facilities, e.g., nursing homes, in response to the COVID-19 public health emergency. • Expenses for technical assistance to local authorities or other entities on mitigation of COVID-19-related threats to public health and safety. • Expenses for public safety measures undertaken in response to COVID-19. • Expenses for quarantining individuals. 3. Payroll expenses for public safety, public health, health care, human services, and similar employees whose services are substantially dedicated to mitigating or responding to the COVID- 19 public health emergency. 4. Expenses of actions to facilitate compliance with COVID-19-related public health measures, such as: • Expenses for food delivery to residents, including, for example, senior citizens and other vulnerable populations, to enable compliance with COVID-19 public health precautions. • Expenses to facilitate distance learning, including technological improvements, in connection with school closings to enable compliance with COVID-19 precautions. • Expenses to improve telework capabilities for public employees to enable compliance with COVID-19 public health precautions. • Expenses of providing paid sick and paid family and medical leave to public employees to enable compliance with COVID-19 public health precautions. • COVID-19-related expenses of maintaining state prisons and county jails, including as relates to sanitation and improvement of social distancing measures, to enable compliance with COVID-19 public health precautions. • Expenses for care for homeless populations provided to mitigate COVID-19 effects and enable compliance with COVID-19 public health precautions. 5. Expenses associated with the provision of economic support in connection with the COVID-19 public health emergency, such as: • Expenditures related to the provision of grants to small businesses to reimburse the costs of business interruption caused by required closures. • Expenditures related to a State, territorial, local, or Tribal government payroll support program. Unemployment insurance costs related to the COVID-19 public health emergency if such costs will not be reimbursed by the federal government pursuant to the CARES Act or otherwise. 6. Any other COVID-19-related expenses reasonably necessary to the function of government that satisfy the Fund's eligibility criteria. Nonexclusive examples of ineligible expenditures3 The following is a list of examples of costs that would not be eligible expenditures of payments from the Fund. 1 Expenses for the State share of Medicaid.4 2. Damages covered by insurance. 3. Payroll or benefits expenses for employees whose work duties are not substantially dedicated to mitigating or responding to the COVID-19 public health emergency. 3 In addition, pursuant to section 5001(b) of the CARES Act, payments from the Fund may not be expended for an elective abortion or on research in which a human embryo is destroyed, discarded, or knowingly subjected to risk of injury or death. The prohibition on payment for abortions does not apply to an abortion if the pregnancy is the result of an act of rape or incest; or in the case where a woman suffers from a physical disorder, physical injury, or physical illness, including a life -endangering physical condition caused by or arising from the pregnancy itself, that would, as certified by a physician, place the woman in danger of death unless an abortion is performed. Furthermore, no government which receives payments from the Fund may discriminate against a health care entity on the basis that the entity does not provide, pay for, provide coverage of, or refer for abortions. 4 See 42 C.F.R. § 433.51 and 45 C.F.R. § 75.306. 4. Expenses that have been or will be reimbursed under any federal program, such as the reimbursement by the federal government pursuant to the CARES Act of contributions by States to State unemployment funds. 5. Reimbursement to donors for donated items or services. 6. Workforce bonuses other than hazard pay or overtime. 7. Severance pay. 8. Legal settlements. Supplemental Guidance on Use of Funds to Cover Payroll and Benefits of Public Employees As discussed in the Guidance above, the CARES Act provides that payments from the Fund must be used only to cover costs that were not accounted for in the budget most recently approved as of March 27, 2020. As reflected in the Guidance and FAQs, Treasury has not interpreted this provision to limit eligible costs to those that are incremental increases above amounts previously budgeted. Rather, Treasury has interpreted this provision to exclude items that were already covered for their original use (or a substantially similar use). This guidance reflects the intent behind the Fund, which was not to provide general fiscal assistance to state governments but rather to assist them with COVID-19-related necessary expenditures. With respect to personnel expenses, though the Fund was not intended to be used to cover government payroll expenses generally, the Fund was intended to provide assistance to address increased expenses, such as the expense of hiring new personnel as needed to assist with the government's response to the public health emergency and to allow recipients facing budget pressures not to have to lay off or furlough employees who would be needed to assist with that purpose. Substantially different use As stated in the Guidance above, Treasury considers the requirement that payments from the Fund be used only to cover costs that were not accounted for in the budget most recently approved as of March 27, 2020, to be met if either (a) the cost cannot lawfully be funded using a line item, allotment, or allocation within that budget or (b) the cost is for a substantially different use from any expected use of funds in such a line item, allotment, or allocation. Treasury has provided examples as to what would constitute a substantially different use. Treasury provided (in FAQ A.3) that costs incurred for a substantially different use would include, for example, the costs of redeploying educational support staff or faculty to develop online learning capabilities, such as through providing information technology support that is not part of the staff or faculty's ordinary responsibilities. Substantially dedicated Within this category of substantially different uses, as stated in the Guidance above, Treasury has included payroll and benefits expenses for public safety, public health, health care, human services, and similar employees whose services are substantially dedicated to mitigating or responding to the COVID- 19 public health emergency. The full amount of payroll and benefits expenses of substantially dedicated employees may be covered using payments from the Fund. Treasury has not developed a precise definition of what "substantially dedicated" means given that there is not a precise way to define this term across different employment types. The relevant unit of government should maintain documentation of the "substantially dedicated" conclusion with respect to its employees. If an employee is not substantially dedicated to mitigating or responding to the COVID-19 public health emergency, his or her payroll and benefits expenses may not be covered in full with payments from the Fund. A portion of such expenses may be able to be covered, however, as discussed below. Public health and public safety In recognition of the particular importance of public health and public safety workers to State, local, and tribal government responses to the public health emergency, Treasury has provided, as an administrative accommodation, that a State, local, or tribal government may presume that public health and public safety employees meet the substantially dedicated test, unless the chief executive (or equivalent) of the relevant government determines that specific circumstances indicate otherwise. This means that, if this presumption applies, work performed by such employees is considered to be a substantially different use than accounted for in the most recently approved budget as of March 27, 2020. All costs of such employees may be covered using payments from the Fund for services provided during the period that begins on March 1, 2020, and ends on December 30, 2020. In response to questions regarding which employees are within the scope of this accommodation, Treasury is supplementing this guidance to clarify that public safety employees would include police officers (including state police officers), sheriffs and deputy sheriffs, firefighters, emergency medical responders, correctional and detention officers, and those who directly support such employees such as dispatchers and supervisory personnel. Public health employees would include employees involved in providing medical and other health services to patients and supervisory personnel, including medical staff assigned to schools, prisons, and other such institutions, and other support services essential for patient care (e.g., laboratory technicians) as well as employees of public health departments directly engaged in matters related to public health and related supervisory personnel. Not substantially dedicated As provided in FAQ A.47, a State, local, or tribal government may also track time spent by employees related to COVID-19 and apply Fund payments on that basis but would need to do so consistently within the relevant agency or department. This means, for example, that a government could cover payroll expenses allocated on an hourly basis to employees' time dedicated to mitigating or responding to the COVID-19 public health emergency. This result provides equitable treatment to governments that, for example, instead of having a few employees who are substantially dedicated to the public health emergency, have many employees who have a minority of their time dedicated to the public health emergency. Covered benefits Payroll and benefits of a substantially dedicated employee may be covered using payments from the Fund to the extent incurred between March 1 and December 30, 2020. Payroll includes certain hazard pay and overtime, but not workforce bonuses. As discussed in FAQ A.29, hazard pay may be covered using payments from the Fund if it is provided for performing hazardous duty or work involving physical hardship that in each case is related to COVID-19. This means that, whereas payroll and benefits of an employee who is substantially dedicated to mitigating or responding to the COVID-19 public health emergency may generally be covered in full using payments from the Fund, hazard pay specifically may only be covered to the extent it is related to COVID-19. For example, a recipient may use payments from the Fund to cover hazard pay for a police officer coming in close contact with members of the public to enforce public health or public safety orders, but across-the-board hazard pay for all members of a police department regardless of their duties would not be able to be covered with payments from the Fund. This position reflects the statutory intent discussed above: the Fund was intended to be used to help governments address the public health emergency both by providing funds for incremental expenses (such as hazard pay related to COVID-19) and to allow governments not to have to furlough or lay off employees needed to address the public health emergency but was not intended to provide across-the-board budget support (as would be the case if hazard pay regardless of its relation to COVID-19 or workforce bonuses were permitted to be covered using payments from the Fund). Relatedly, both hazard pay and overtime pay for employees that are not substantially dedicated may only be covered using the Fund if the hazard pay and overtime pay is for COVI D-1 9 -related duties. As discussed above, governments may allocate payroll and benefits of such employees with respect to time worked on COVID-19-related matters. Covered benefits include, but are not limited to, the costs of all types of leave (vacation, family -related, sick, military, bereavement, sabbatical, jury duty), employee insurance (health, life, dental, vision), retirement (pensions, 401(k)), unemployment benefit plans (federal and state), workers compensation insurance, and Federal Insurance Contributions Act (FICA) taxes (which includes Social Security and Medicare taxes). Supplemental Guidance on Use of Funds to Cover Administrative Costs General Payments from the Fund are not administered as part of a traditional grant program and the provisions of the Uniform Guidance, 2 C.F.R. Part 200, that are applicable to indirect costs do not apply. Recipients may not apply their indirect costs rates to payments received from the Fund. Recipients may, if they meet the conditions specified in the guidance for tracking time consistently across a department, use payments from the Fund to cover the portion of payroll and benefits of employees corresponding to time spent on administrative work necessary due to the COVID-19 public health emergency. (In other words, such costs would be eligible direct costs of the recipient). This includes, but is not limited to, costs related to disbursing payments from the Fund and managing new grant programs established using payments from the Fund. As with any other costs to be covered using payments from the Fund, any such administrative costs must be incurred by December 30, 2020, with an exception for certain compliance costs as discussed below. Furthermore, as discussed in the Guidance above, as with any other cost, an administrative cost that has been or will be reimbursed under any federal program may not be covered with the Fund. For example, if an administrative cost is already being covered as a direct or indirect cost pursuant to another federal grant, the Fund may not be used to cover that cost. Compliance costs related to the Fund As previously stated in FAQ B.11, recipients are permitted to use payments from the Fund to cover the expenses of an audit conducted under the Single Audit Act, subject to the limitations set forth in 2 C.F.R. § 200.425. Pursuant to that provision of the Uniform Guidance, recipients and subrecipient's subject to the Single Audit Act may use payments from the Fund to cover a reasonably proportionate share of the costs of audits attributable to the Fund. To the extent a cost is incurred by December 30, 2020, for an eligible use consistent with section 601 of the Social Security Act and Treasury's guidance, a necessary administrative compliance expense that relates to such underlying cost may be incurred after December 30, 2020. Such an expense would include, for example, expenses incurred to comply with the Single Audit Act and reporting and recordkeeping requirements imposed by the Office of Inspector General. A recipient with such necessary administrative expenses, such as an ongoing audit continuing past December 30, 2020, that relates to Fund expenditures incurred during the covered period, must report to the Treasury Office of Inspector General by the quarter ending September 2021 an estimate of the amount of such necessary administrative expenses. Exhibit B Benton -Franklin Community Test Site — Term Sheet H 09.22.2020 Benton Franklin Health District: (Commons and DOH will support) • Test site selection and securing appropriate contracting documentation with site owner • Infection control protocols, initial inventory of PPE and put in place a system for on-going inventory management • Long terms procurement of supplies -- Ongoing Kits, PPE • Local procurement of technology/tents/tables/supplies to operate test site (as needed) • Logistics support • Patient communication design including multi-lingual patient handouts and scripts that incorporate language accessibility • Provide signage and supplies to manage flow and redirect traffic (e.g., pylons, barricades), and support accessibility goals • Ordering Physician unless otherwise provided by EMS Medical Command • Lab Courier Service (maybe bundled with reference lab contract) • Set up notification process / customer service for positive patients (consider contract / partnering with local agency) • Facilitate on-site staff access to Language line for non-English speaking customers Pasco Fire: (Commons, EOC and GCACH will support) • Local test site command (scheduling/daily operations) • Recruit Columbia Safety to run daily test site operations • Ensure Local test site is supplied/organized to operate • Timely requests to EOC for any supplies to ensure no gaps in materials • Site plan including an agreed upon traffic flow with local jurisdiction • Supervise and assure safety for all personnel while onsite • Monthly financial activity reports detailing expenditures for which reimbursement is requested • Monthly labor reports to BFHD for direct payment (Fire District name, employee name, date(s), hours worked and any other documentation to assist DOH with validation of invoices to reimburse Fire Districts for operational labor support) • Maintain additional financial backup documentation such as payroll and general ledger and provide upon request • Other reporting as requested by DOH • A positive patient experience Greater Columbia ACH: (Pasco Fire and EOC will support) City of Pasco — Contract 2020 a g e 1 1 • Developing and implementing marketing strategy for test site • Partner with local community advocates, employers, leaders and county agencies to ensure community is knowledgeable about test site. Columbia Safety: (Pasco Fire to support) • Recruiting, hiring, onboarding, and continued HR support of Swabbers, Registered Technician Leads, Registered Technicians, and Traffic Positions • A positive patient experience DOH/HCA: (EOC and Commons will support) • Funding for BFHD and Pasco Fire to set up and operate test sites • Reference Lab and software selection/contracting with those suppliers • Ongoing Kits, PPE as needed SOLV Health: (Commons will support) • Provide technical software to support customer registration, sample collection, lab processing, and result notification (QR code) • Provide dry run and launch support to site team and staff • Work with UW Med Lab, Commons and site team to ensure quick resolution of any IT related bugs/issues UW Med Lab: (Pasco Fire and BFHD will support) • Provide testing for all samples collected at site • Provide technical and workflow feedback related to specimen collection errors • Provide courier services and pick-up on-site Thursday -Monday • Provide cardboard test tube containers to BFHD Commons: (EOC and DOH will support) • Overall Program Management • Consumer marketing / demand generation for local site/registration website • Configuration of registration software/timekeeping and related technology • Initial training and scheduling of personnel to administer tests, registration staff, traffic control, and parking enforcement • Establish on-site laboratory protocols and create touchpoints between CTS, site supervisors and lab to ensure open communication and continuous improvement • Support local Fire with initial set up, training and site operations City of Pasco—Contract 2020 F € e 12 Vendor Invoice Template City of Pasco - Fire Department 1011 E Ainsworth Ave Pasco WA 99330 Remit To Benton -Franklin Health District Attn: Accounts Payable 7102 W Okanogan Place Kennewick WA 99336 Exhibit C Contract # Contact Phone # Email Invoice for services rendered under this contract for the period of: SalariesMa es REG OT REGULAR PAY OT PAY EMPLOYEE POSITION HRSNVK/MO HRS/WK/MO RATE RATE TOTAL Incident Command 0.00 0.00 $0.00 $0.00 $0.00 Operation/Safety Chief 0.00 0.00 $0.00 $0.00 $0.00 Finance Section Chief 0.00 0.00 $0.00 $0.00 $0.00 Planning Section Chief 0.00 0.00 $0.00 $0.00 $0.00 Logistics Chief 0.00 0.00 $0.00 $0.00 $0.00 On Site Supervisor 0.00 0.00 $0.00 $0.00 $0.00 Clinician 0.00 0.00 $0.00 $0.00 $0.00 Clinician 0.00 0.00 $0.00 $0.00 $0.00 Clinician 0.00 0.00 $0.00 $0.00 $0.00 Clinician 0.00 0.00 $0.00 $0.00 $0.00 Clinician 0.00 0.00 $0.00 $0.00 $0.00 Clinician 0.00 0.00 $0.00 $0.00 $0.00 RT- Lead 0.00 0.00 $0.00 $0.00 $0.00 RT 0.00 0.00 $0.00 $0.00 $0.00 RT 0.00 0.00 $0.00 $0.00 $0.00 RT 0.00 0.00 $0.00 $0.00 $0.00 RT 0.00 0.00 $0.00 $0.00 $0.00 RT 0.00 0.00 $0.00 $0.00 $0.00 RT 0.00 0.00 $0.00 $0.00 $0.00 Parking Enforcement 0.00 0.00 $0.00 $0.00 $0.00 Traffic Civilian 0.00 0.00 $0.00 $0.00 $0.00 Total SalariesMa es $0.00 City of Pasco - Contract 2020 a g e 1 1 Vendoes Certificate: I hereby certify under penalty of perjury that the items and totals listed herein are proper charges for materials, merchandise or services furnished and that all goods furnished and/or services rendered have been provided without discrimination because of age, sex, marital status, race, creed, color, national origin, handicap, religion, or Vietnam era or disabled veterans status. Print Name & Title Signature Date City of Pasco—Contract 2020 P 6 12 Total Benefits -Fringe $0.00 Supplies & Equipment Descri tion Amount Office Supplies Medical Supplies Minor Equipment Other: Total Supplies & Equipment $0.00 TOTAL EXPENDITURES $0.00 Vendoes Certificate: I hereby certify under penalty of perjury that the items and totals listed herein are proper charges for materials, merchandise or services furnished and that all goods furnished and/or services rendered have been provided without discrimination because of age, sex, marital status, race, creed, color, national origin, handicap, religion, or Vietnam era or disabled veterans status. Print Name & Title Signature Date City of Pasco—Contract 2020 P 6 12 6 D DEPARTMENT OF IiEALTIi & IWMAN SERVICES Office of the Secretary The General Counsel Washington, D.C. 20201 ADVISORY OPINION ON THE PUBLIC READINESS AND EMERGENCY PREPAREDNESS ACT AND THE MARCH 10, 2020 DECLARATION UNDER THE ACT APRIL 17, 2020, AS MODIFIED ON MAY 19, 2020 Purpose of this Advisory Opinion On March 10, 2020, the Secretary of Health and Human Services (Secretary) issued a Declaration under the Public Readiness and Emergency Preparedness Act (PREP Act), effective February 4, 2020, for certain medical products to be used against COVID-19. See 85 Fed. Reg. 15,198, 15,202 (March 17, 2020); see also Pub. L. No. 109-148, Public Health Service Act § 3191-3, 42 U.S.C. § 247d -6d and 42 U.S.C. § 247d -6e. We have received requests for advisory opinions, especially from those donating goods and services, on whether various activities qualify for PREP Act immunity. The Office of the General Counsel will make every effort to respond to each request. But we have limited resources, especially in this time of national emergency. To minimize the need to request an advisory opinion, we issue this omnibus advisory opinion that should address most questions and concerns about the scope of PREP Act immunity during the Coronavirus disease 2019 (COVID-19) pandemic. This advisory opinion sets forth the current views of the Office of the General Counsel.' It is not a final agency action or a final order. Nor does it bind HHS or the federal courts. It does not have the force or effect of law. The PREP Act PREP Act immunity applies to any "covered person" with respect to all "claims for loss" caused by, arising out of, relating to, or resulting from the "administration" or the "use" of a "covered countermeasure" if a declaration has been issued with respect to that countermeasure. 42 U.S.C. § 247d-6d(a)(1). We often receive questions about whether a medical product is a covered countermeasure, whether a person is a covered person, and whether a specific activity qualifies as use or administration of a covered countermeasure. Therefore, this advisory opinion • provides a list of covered countermeasures subject to an Emergency Use Authorization (EUA);"` ' See Air Brake Sys, Inc. r.: Minela, 357 F.3d 632, 647-48 (6th Cir. 2004) (holding that the Chief Counsel of the National Highway Traffic Safety Administration had delegated authority to issue advisory opinions to regulated entities in fulfillment of a congressional directive to promote regulatory compliance); 5 U.S.C. § 301 ("The head of an executive department ... may prescribe regulations for the government of his department, the conduct of its employees, [and] the distribution and performance of its businessf.]'D. -' See. Appendix A, https://www.fda.gov/media/136702/download Appendix B, /inedia/ l 36832/download . advises that an entity or individual who complies with all other requirements of the PREP Act and the conditions of the Secretary's declaration will not lose PREP Act immunity—even if the medical product at issue is not a covered countermeasure—if that entity or individual reasonably could have believed that the product was a covered countermeasure; • advises that a person who complies with all other requirements of the PREP Act and the conditions of the Secretary's declaration will not lose PREP Act immunity—even if the person at issue is not a covered person—if the entity or individual reasonably could have believed that the person was a covered person; and sets forth HHS's view that covered persons should take, and document, reasonable precautions under the current emergent circumstances to facilitate the safe use or administration of covered countermeasures and to make those documents publicly and easily available. If all requirements of the PREP Act and the declaration are met, immunity covers claims for loss sounding in tort or contract, as well as claims for loss relating to compliance with local,' state, or federal laws, regulations, or other legal requirements. Immunity applies when a covered person engages in activities related to an agreement or arrangement with the federal government, or when a covered person acts according to an Authority Having Jurisdiction to respond to a declared emergency. We interpret these two conditions broadly to include (1) any arrangement with the federal government, or (2) any activity that is part of an authorized emergency response at the federal, regional, state, or local level. Such activities can be authorized through, among other things, guidance, requests for assistance, agreements, or other arrangements. Because the Secretary issued a Public Health Emergency declaration on January 31, 2020, effective as of January 27, 2020, the immunity granted by the PREP Act under this declaration applies regardless of whether state or local authorities have declared states of emergencies. A few caveats about PREP Act immunity: First, PREP Act immunity is not absolute. For example, the PREP Act does not provide immunity against federal enforcement actions brought by the federal government—whether civil, criminal, or administrative. Nor does the PREP Act provide immunity against suit and liability for claims under federal law for equitable relief. PREP Act immunity (exempting preemption) is also limited to claims for personal injury or damage to property. Second, the PREP Act replaces certain damages claims that would normally be brought in court with a no- fault compensation system outlined at 42 C.F.R. pt. 110. Third, PREP Act immunity must be read in light of the PREP Act's broad, express -preemption provision. ' While PREP Act immunity does not expressly extend to local laws, the Act expressly preempts any State and local law that "is different from, or is in conflict with, any requirement applicable under [the PREP Act]." 42 U.S.C. § 247d-6d(b)(8). 4 Under § 247d-6d(b)(8)(A), (1) "no State or political subdivision of a State may establish, enforce, or continue in effect with respect to a covered countermeasure any provision of law or legal requirement that is different from, or is in Conflict Bit& any requirement applicable under this section" 2 Covered Countermeasures The PREP Act authorizes the Secretary to issue a declaration to provide liability immunity to certain individuals and entities (covered persons) against any claim of loss caused by, arising out of, relating to, or resulting from the manufacture, distribution, administration, or use of medical countermeasures (covered countermeasures). Under the March 10, 2020 declaration, covered countermeasures are any antiviral, any other drug, any biologic, any diagnostic, any other device, or any vaccine, used to treat, diagnose, cure, prevent, or mitigate COVID-19, or the transmission of SARS-CoV-2 or a virus mutating therefrom, or any device used in the administration of any such product, and all components and constituent materials of any such product. 85 Fed. Reg. 15,198, 15,202 {March 17, 2020). Any drug, device, or biological product that is approved, cleared, or licensed by the FDA and is used to diagnose, mitigate, prevent, treat, cure, or limit the harm of COVID-19 is a covered countermeasure. The Coronavirus Aid, Relief, and Economic Security (CARES) Act § 3103, Pub. L. No. 116-136 (March 27, 2020), amended the PREP Act to add respiratory protective devices to the list of covered countermeasures so long as they are NIOSH approved and determined by the Secretary to be a priority for use during a public health emergency declared by the Secretary under section 319 of the Public Health Service Acts See 42 U.S.C. § § 247d, 247d-6d(i)(1)(D). Any drug, device, or biological product authorized for emergency use with respect to COVID-19 under an EUA, described in Emergency Use Instructions (EUI) issued by the CDC, or being researched under certain investigational provisions (i.e., IND, IDE) to treat COVID-19 is a covered countermeasure. See 21 C.F.R. pts. 312 and 812. In addition, as noted above, the CARES Act amended the PREP Act to include certain respiratory protective devices. These requirements apply equally to products held in the public and private sectors. Covered countermeasures include, among other things, a "qualified pandemic or epidemic product." See 42 U.S.C. § 247d-6d(i)(1)(A). The term "qualified pandemic or epidemic produce, means a drug ... biological product ... or device [as] defined ... [in] the Federal Food, Drug, and Cosmetic Act ... that is (A) n a product manufactured, used, designed, developed, modified, licensed, or procured— (1) to diagnose, mitigate, prevent, treat, or cure a pandemic or epidemic; or (II) to limit the harm such pandemic or epidemic might otherwise cause; and (2) relates to, among other things, use or administration of the covered countermeasure. (Emphasis added). S The Secretary issued an amendment to the Declaration effective March 27, 2020 to address this statutory change. 85 Fed. Reg. 21,012 (April 15, 2020). (n) a product manufactured, used, designed, developed, modified, licensed, or procured to diagnose, mitigate, prevent, treat, or cure a serious or life-threatening disease or condition caused by a product described in clause (); or (iii) a product or technology intended to enhance the use or effect of a drug, biological product, or device described in clause (i) or (ii); and (B) (i) approved or cleared under chapter V of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. § 351 etseq.] or licensed under section 262 of this title; (u) the object of research for possible use as described by subparagraph (A) and is the subject of an exemption under section 505(1) or 520(8) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. % 355(i), 360j(g)]; or (iii) authorized for emergency use in accordance with section 564, 564A, or 564B of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. % 360bbb-3, 360bbb-3a, 360bbb-3b]. 42 U.S.C. § 247d-6d(i)(7). Thus, in order to meet the definition of a qualified pandemic or epidemic product, a product (1) must be used for COVID-19; and (2) must be (a) approved, licensed, or cleared by FDA; (b) authorized under an EUA; (c) described in an EUI; or (d) used under either an Investigational New Drug (IND) application or an Investigational Device Exemption (IDE).' The number of products used for COVID-19 that are approved, licensed, or cleared are too numerous to list. But we have found that industry has often sought clarity regarding whether certain products, including diagnostic tests and personal protective equipment (PPE), are covered by EUAs. Footnote 2, above, links to a list those products that are covered by EUAs. We hope that this list proves helpful. HHS will use its best efforts to regularly update that list, although there may be a lag between the actual issuance of the EUA by FDA and the product's appearance on the list. Given the broad scope of PREP Act immunity, Congress did not intend to impose a strict - liability standard on covered persons for determining whether a product is a covered countermeasure. Instead, we believe that a person or entity that otherwise meets the requirements for PREP Act immunity will not lose that immunity—moven if the product is not a covered countermeasure—if that person or entity reasonably could have believed that the product was a covered countermeasure. See, e.g., 42 U.S.C. § 247d-6d(a)(4)(B) (applying the "reasonably -could -have -believed" standard to predicate 6 While certain information about products under an IND or IDE is confidential commercial information and not subject to disclosure, some information is available to the public on clinicaltrials.gov. 4 requirements for PREP Act immunity not involving the actual use and administration of covered countermeasures). For example, FDA has issued EUAs for certain COVID-19 tests and PPE. A covered person purchases 500,000 tests or respirators that appear to be authorized under an EUA. The covered person has taken reasonable steps—under the current, emergent circumstances—to substantiate the authenticity of the products. But it turns out that some or all of the products are counterfeit. Under those circumstances, we believe that the person would be immune against a claim arising out of the use of a counterfeit test or respirator. Covered Person The PREP Act provides immunity to a "covered person" for certain activities (e.g., manufacturing, distributing, using, or administering) involving a "covered countermeasure," as defined in the PREP Act and delineated in a PREP Act declaration issued by the Secretary. The term "covered person," when used with respect to the administration or use of a covered countermeasure, means (A) the United States; or (B) a person or entity that is— (i) a manufacturer of such countermeasure; (ii) a distributor of such countermeasure; ('iii) a program planner of such countermeasure; (iv) a qualified person who prescribed, administered, or dispensed such countermeasure; or (v) an official, agent, or employee of a person or entity described in clause (i), (ii), (iii), or (iv). 42 U.S.C. § 247d-6d(i)(2). We have received questions about the meaning of "program planner" and "qualified person." The term "program planner" means a State or local government, including an Indian tribe, a person employed by the State or local government, or other person who supervised or administered a program with respect to the administration, dispensing, distribution, provision, or use of a security countermeasure or a qualified pandemic or epidemic product, including a person who has established requirements, provided policy guidance, or supplied technical or scientific advice or assistance or provides a facility to administer or use a covered countermeasure in accordance with [the Secretary's declaration]. 42 U.S.C. § 247d-6d(t (6). 5 Under the Secretary's declaration, "[A] private sector employer or community group or other `person' can be a program planner when it carries out the described activities." 85 Fed. Reg. at 15,202. The term "qualified person," when used with respect to the administration or use of a covered countermeasure, means— (A) a licensed health professional or other individual who is authorized to prescribe, administer, or dispense such countermeasures under the law of the State in which the countermeasure was prescribed, administered, or dispensed; or (B) a person within a category of persons so identified in a declaration by the Secretary. 42 U.S.C. § 247d-6d(i)(8). With respect to that second category, the Secretary, through Section V of his declaration, has determined that qualified persons also include [a]ny person authorized in accordance with the public health and medical emergency response of the Authority Having Jurisdiction, as described in Section VII below, to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures, and their officials, agents, employees, contractors and volunteers, following a Declaration of an emergency[.] 85 Fed. Reg. at 15,202. Therefore, an Authority Having Jurisdiction has broad powers to extend PREP Act immunity to additional individuals as part of a public health and medical emergency response. The Authority Having Jurisdiction does so by authorizing "any person" to "prescribe, administer, deliver, distribute or dispense the Covered Countermeasures." Section VII of the declaration explains that "[t]he Authority Having Jurisdiction means the public agency or its delegate that has legal responsibility and authority for responding to an incident, based on political or geographical (e.g., city, county, tribal, state, or federal boundary lines) or functional (e.g., law enforcement, public health) range or sphere of authority." Id. As the lead federal public-health agency that has legal responsibility and authority for responding to the COVID-19 emergency, HHS is an Authority Having Jurisdiction, but it is not the only Authority Having Jurisdiction to respond to the COVID-19 emergency. The following is an example of a qualified person under Sections V and VII of the declaration. In response to the COVID-19 emergency, the HHS Office of the Assistant Secretary for Health (OASH) issued guidance for licensed pharmacists to order and administer COVID-19 tests, including serology tests, that the FDA has authorized. Such tests are covered countermeasures under the declaration. Thus, under Sections V and VII of the declaration, such pharmacists are covered persons. Specifically, they are qualified persons, as they are acting in accordance with guidance from HHS—an Authority Having Jurisdiction to respond—following a declared emergency by the Secretary. The pharmacists are covered as qualified persons (and hence as covered persons) even if they may not be licensed or authorized by the State to prescribe the tests pursuant to § 247d-6d(i)(8)(A)), because they fit within the alternative definition of "qualified persons" pursuant to paragraph § 247d-6dn(8)(B), as provided by the Secretary in the declaration. As with covered countermeasures, an entity or person that otherwise meets the requirements for PREP Act immunity will not lose that immunity—even if the entity or person is not a covered person if that entity or person reasonably could have believed, under the current, emergent circumstances, that the person was a covered person. See, e.g., 42 U.S.C. § 247d-6d(a)(4)(B). For example, a pharmacy allows its licensed pharmacists to order FDA -authorized, self -swab COVID-19 tests pursuant to the CASH guidance. Notwithstanding the pharmacy's reasonable - compliance measures to ensure current licensure, it turns out that one of the pharmacists had inadvertently allowed his license to expire. Under those circumstances, the pharmacy would still be immune against a lawsuit relating to the COVID-19 test prescribed by that pharmacist. Reasonable Precautions Under the PREP Act, immunity is broad. As a general matter, a covered person is immune from liability for all claims for loss except for willful misconduct that proximately caused death or serious injury. 42 U.S.C. § 247d-6d(c)(3). Suits alleging an exception to immunity for covered persons can only be brought before a three-judge court in the United States District Court for the District of Columbia. 42 U.S.C. § 247d-6d(e)(1), (5). And to prevail, a plaintiff must establish, by clear and convincing evidence, that the willful misconduct proximately caused death or serious injury. 42 U.S.C. § 247d-6d(c)(3). But even then, certain acts or omissions remain immune from suit. For example, under 42 U.S.C. § 247d-6d(c)(4), Notwithstanding any other provision of law, a program planner or qualified person shall not have engaged in "willful misconduct" as a matter of law where such program planner or qualified person acted consistent with applicable directions, guidelines, or recommendations by the Secretary regarding the administration or use of a covered countermeasure that is specified in the declaration under subsection (b), provided either the Secretary, or a State or local health authority, was provided with notice of information regarding serious physical injury or death from the administration or use of a covered countermeasure that is material to the plaintiff's alleged loss within 7 days of the actual discovery of such information by such program planner or qualified person. And under 42 U.S.C. § 247d-6d(c)(5), certain acts or omissions by a manufacturer or distributor and "subject to regulation by this chapter or by the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.]" will not constitute willful misconduct if (1) "neither the Secretary nor the Attorney General has initiated an enforcement action with respect to such act or omission" or (2) "such an enforcement action has been initiated and the action has been terminated or finally resolved without a covered remedy." Nevertheless, HHS encourages all covered persons using or administering covered countermeasures to document the reasonable precautions they have taken to safely use the covered countermeasures. For example, consider a distributor of medical products that sources PPE from a new supplier abroad in a good -faith attempt to quickly deliver PPE to American communities affected by COVID- 19. Among other things, that distributor assesses the supplier's facility to confirm that the supplier actually manufactures the PPE. The distributor also confirms that the supplier has quality -control processes in place. Under those circumstances, the distributor may wish to make available to the purchaser information about the reasonable efforts that the distributor had taken to safely use the covered countermeasures. Purchasers such as hospitals would then be able to make more informed decisions about how best to use the PPE. Overall, this would provide greater transparency in implementing the PREP Act. Compensation for Injuries The PREP Act, like workers' compensation or the National Vaccine Injury Compensation Program, substitutes a no-fault, speedy compensation system in place of expensive and uncertain litigation. Those who have been seriously injured or died as the direct result of a covered countermeasure administered or used under a declaration may seek compensation from the Covered Countermeasures Process Fund. Requests for benefits must be made to the Health Resources and Services Administration's Countermeasures Injury Compensation Program (CICP). Compensation for serious injuries may be available to eligible requesters under CICP. A serious injury generally means a physical injury that warranted hospitalization (whether or not the person was actually hospitalized) or that led to a significant loss of function or disability. 42 C.F.R. § 110.3(z). CICP pays reasonable and necessary medical benefits. CICP also pays lost wages to eligible recipients. Death benefits may also be available to certain survivors of eligible individuals who died as a direct result of the administration or use of a covered countermeasure. CICP is payer of last resort. So benefits are reduced by the amounts payable by other public and private third -party payers (such as health insurance and workers' compensation). The regulations implementing the CICP are at 42 C.F.R. pt. 110. Compensation for injuries is more limited than the liability immunity afforded under the PREP Act. As described above, the PREP Act provides immunity for all claims for loss. But CICP will provide compensation only for eligible claims of serious physical injury or death. CICP will not compensate claims related to emotional injury, fear of injury, business losses, or other types of claims for which immunity is provided. Information about this program can be found at hulas:/ /%%AMw,hrsa. ov is Z aboutZindc:x,httnl or by calling 855-266-2427. Limitations This Advisory Opinion may be supplemented or modified. It is intended to minimize the need for individual advisory opinions. E. Persons seeking PREP Act immunity are responsible for determining whether their products are covered countermeasures, whether a person or entity is a covered person, whether reasonable precautions have been taken to facilitate the safe use of covered countermeasures, and in general, whether immunity applies to them and their activities. kab f- P. ch4 YlJ`W" Robert P. Charrow General Counsel May 19, 2020